Clinical Development Medical Director; MD

The Clinical Development Medical Director (Director) ensures medical & scientific integrity and the wellbeing of participants enrolled in clinical trials, designs and executes high-quality studies, maintains compliance, manages risks and emerging clinical and medical issues, and supports interpretation and communication of clinical data. This role is the primary contact for internal and external stakeholders for clinical and medical aspects the protocol, supports strategic development, and may provide matrix management.

• Leadership

  • Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact. May be accountable for program level clinical deliverables.

  • Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.

  • May provide matrix management support to one or more clinical colleagues.

• Content Creation

  • Provides clinical/medical input to support development of the protocol design document (PDD).

  • Leads development of the protocol from the approved PDD and ensures efficient protocols which maximize operational efficiency, trial quality and participant / site engagement and which minimize the likelihood of amendments or quality issues. Partners with/ supports the Global Development Lead in governance review and approval process.

  • Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.

• • Authors and manages approval of Informed Consent Documents (ICDs) including responses to external stakeholder questions.

• Clinical & Safety Oversight

• • Performs medical monitoring on one or more clinical trials

  • Provides study-related medical information and assistance, e.g., on:

    • medical questions from investigators, site personnel and non-study health care providers

    • safety findings, medical issues, and complex serious adverse events

    • audits or inspection medical responses

  • Provides clinical/medical input to the development of data collection tools.

  • Responsible for providing clinical/medical input to statistical analysis plan (SAP), tables, listings, figures (TLFs) and blinded data review (BDR).

  • Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.

  • Provides clinical/medical input to development of the Integrated Quality Management Plan (IQMP). Review and approves final document.

  • Inputs to, reviews, and approves, Risk Management and Safety Review Plan; ensures activities are conducted consistent with the approved plan and partners with key stakeholders (clinical operations, safety risk lead, etc.) to develop and implement any risk mitigations.

  • Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.

  • Serves as the primary contact with external investigators and internal study team for questions relating to clinical/medical aspects of protocol

  • Contributes to final significant quality event medical assessments.

  • Jointly with clinical colleagues, conducts and documents periodic safety data reviews, and ongoing clinical/medical data review.

  • Reviews required safety text and endorses significant medical changes in the ICD.

  • Reviews, reports and manages protocol deviations.

  • Reviews patient level and cumulative data per the data review plan across one or more studies.

  • Reviews safety data, serious adverse event (SAE) reports, targeted medical events (TMEs), designated medical events (DMEs) and ensures clinical documents (eg ICD) are updated as required.

  • Tracks and reconciles SAEs across a study and leads presentation of data during Safety Review Team meetings.

  • Ensures trial master file (TMF) compliance for clinical documents

• Clinical Reporting

  • May contribute to clinical sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure (IB), IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses) if required.

  • May support responsible colleagues with the development of responses to regulatory queries and Clinical Trial Applications (CTAs)

  • Inputs and reviews the Clinical Study Report including the review of narratives. Responsible for supporting disclosure of safety and efficacy data and trial conclusions. Contributes to primary publication of clinical trial results.

  • Provides clinical support to the study team or clinical program in response to audits or inspections, including providing support as needed to audit/inspection

• As medically qualified individual, the successful candidate must have the following qualifications:

• • Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience in biopharmaceutical industry in clinical research and development.

  • Been licensed by a licensing…